Design Quality Engineer II

🕒 vor 4 Tagen

🌪️ Kansas – Remote

🌪️ Kansas – Remote

💵 $65.269 - $169.742 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🔧 QA-Ingenieur (Qualitätssicherung)

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Agiliti

WebsiteLinkedInAlle Stellen

5001 - 10000 Mitarbeiter

Gegründet 1939

🏥 Gesundheitswesen

📦 Logistik

🤝 B2B

Healthcare • Logistics • B2B

Agiliti ist ein Unternehmen im Bereich Gesundheitsdienstleistungen, das medizinische Geräte und klinische Technologien für Gesundheitsdienstleister verwaltet, wartet und unterstützt. Das Unternehmen bietet Außendienstoperationen und Kundenservice, klinische Ingenieurleistungen, Herstellungs- und Ingenieurservices, Technologie- und Informationssysteme sowie Lieferketten-/Logistikdienstleistungen an, die darauf ausgelegt sind, sicherzustellen, dass wichtige Geräte verfügbar und patientenbereit sind. Agiliti positioniert sich als B2B-Partner für Krankenhäuser und Gesundheitsorganisationen und betont dabei eine auf Mission ausgerichtete Kultur, Gemeinwohlarbeit sowie Vielfalt und Inklusion.

Beschreibung

• Utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers. • Act as a team member in supporting quality decisions and practices. • Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Apply statistical methodologies for assessment and to resolve potential product and quality system issues. • Develop and maintain or support the development of testing plans, models and methods for raw materials, materials in process, and finished goods. • Collaborate with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers. • Coordinate planning and execution of first article inspections and approvals. • Coordinate planning, execution, and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams. • Lead activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans. • Plan, develop, and oversee execution of Design verification and validation protocols. • Lead advanced product quality planning activities and assist in preparing new product designs for certification testing. • Participate in projects and cross-functional teams. May lead mid-scale projects.

🎯 Anforderungen

• Bachelor’s Degree (BS) in Engineering, Scientific, or Technical related subject required. • 3-7 yrs. of relevant experience, preferably in Design and Development in an ISO13485, FDA 21CFR820 and MDSAP regulated environment, mainly for the Design Controls process and requirements. • ISO13485 and FDA 21CFR820 highly desired. • Working knowledge and experience with metrology labs preferred and GD&T. • Experience with medical device ISO14971 Risk Management. • Previous working experience in a Design Quality Assurance role for medical device equipment is required. • Working knowledge of IEC 60601-1 Safety standards preferred, but not required. • Use of statistical analysis software for SPC & CPk Analysis • Tooling and fixturing development and qualification (FAI and Gage R&R) • Minimum 3 years of working experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle.

🏖️ Vorteile

• health insurance options for Medical, Dental & Vision plans • Short- and Long-Term Disability plans • Flexible Spending Accounts • Health Savings Accounts • Life Insurance Options • Paid Time Off • 401K Saving Plan with employer match • Employee Discounts • Tuition Reimbursement • Daily Pay program • Employee Assistance Program • wellness programs